title: Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study.
abstract: OBJECTIVE
  Liraglutide, a once-daily human glucagon-like peptide-1 analog, induced clinically meaningful weight loss in a phase 2 study in obese individuals without diabetes. The present randomized phase 3 trial assessed the efficacy of liraglutide in maintaining weight loss achieved with a low-calorie diet (LCD).
  
  
  METHODS
  Obese/overweight participants (≥18 years, body mass index ≥30 kg m(-2) or ≥27 kg m(-2) with comorbidities) who lost ≥5% of initial weight during a LCD run-in were randomly assigned to liraglutide 3.0 mg per day or placebo (subcutaneous administration) for 56 weeks. Diet and exercise counseling were provided throughout the trial. Co-primary end points were percentage weight change from randomization, the proportion of participants that maintained the initial ≥5% weight loss, and the proportion that lost ≥5% of randomization weight (intention-to-treat analysis). ClinicalTrials.gov identifier: NCT00781937.
  
  
  RESULTS
  Participants (n=422) lost a mean 6.0% (s.d. 0.9) of screening weight during run-in. From randomization to week 56, weight decreased an additional mean 6.2% (s.d. 7.3) with liraglutide and 0.2% (s.d. 7.0) with placebo (estimated difference -6.1% (95% class intervals -7.5 to -4.6), P<0.0001). More participants receiving liraglutide (81.4%) maintained the ≥5% run-in weight loss, compared with those receiving placebo (48.9%) (estimated odds ratio 4.8 (3.0; 7.7), P<0.0001), and 50.5% versus 21.8% of participants lost ≥5% of randomization weight (estimated odds ratio 3.9 (2.4; 6.1), P<0.0001). Liraglutide produced small but statistically significant improvements in several cardiometabolic risk factors compared with placebo. Gastrointestinal (GI) disorders were reported more frequently with liraglutide than placebo, but most events were transient, and mild or moderate in severity.
  
  
  CONCLUSIONS
  Liraglutide, with diet and exercise, maintained weight loss achieved by caloric restriction and induced further weight loss over 56 weeks. Improvements in some cardiovascular disease-risk factors were also observed. Liraglutide, prescribed as 3.0 mg per day, holds promise for improving the maintenance of lost weight.
authors.affiliation: Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: T A
authors.initials: TA
authors.lastname: Wadden
authors.forename: P
authors.initials: P
authors.lastname: Hollander
authors.forename: S
authors.initials: S
authors.lastname: Klein
authors.forename: K
authors.initials: K
authors.lastname: Niswender
authors.forename: V
authors.initials: V
authors.lastname: Woo
authors.forename: P M
authors.initials: PM
authors.lastname: Hale
authors.forename: L
authors.initials: L
authors.lastname: Aronne
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019440:Anti-Obesity Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D031204:Caloric Restriction / Q000379:methods; D002170:Canada / Q000453:epidemiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005081:Exercise Therapy; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D000069450:Liraglutide; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D015431:Weight Loss / Q000187:drug effects
chemical_list: D019440:Anti-Obesity Agents; D000069450:Liraglutide; D052216:Glucagon-Like Peptide 1